| CTRI Number |
CTRI/2025/11/097972 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Understanding School Difficulties in Children with blood cancer through occupational therapy |
|
Scientific Title of Study
|
Occupational Therapy focused assessment of Schooling Capabilities in pediatric Acute Lymphoblastic Leukemia patients: A prospective observational study |
| Trial Acronym |
ALL-SCOT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4878 version 1.1 dated 6 August 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjusha Vagal |
| Designation |
Professor and Office In-Charge, Occupational therapy department |
| Affiliation |
Tata Memorial Hospital and Research Centre |
| Address |
Room number 94, Main building, Occupational Therapy Department, Tata Memorial Hospital, Parel 12, Mumbai, Maharashtra. Dr. E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manjusha Vagal |
| Designation |
Professor and Office In-Charge, Occupational therapy department |
| Affiliation |
Tata Memorial Hospital and Research Centre |
| Address |
Room number 94, Main building, Occupational Therapy Department, Tata Memorial Hospital, Parel 12, Mumbai, Maharashtra. Dr. E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjusha Vagal |
| Designation |
Professor and Office In-Charge, Occupational therapy department |
| Affiliation |
Tata Memorial Hospital and Research Centre |
| Address |
Room number 94, Main building, Occupational Therapy Department, Tata Memorial Hospital, Parel 12, Mumbai, Maharashtra. Dr. E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9867552266 |
| Fax |
|
| Email |
vagalmanjusha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital and Research Centre |
| Address |
Dr E Borges Road, Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Manjusha Vagal |
Tata Memorial Hospital |
Room number 94, Main building, Occupational Therapy Department, Tata Memorial Hospital, Parel 12, Mumbai, Maharashtra. Dr. E Borges Road, Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
09867552266
vagalmanjusha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Acute lymphoblastic leukemia
2. Age range 6-16 years
3. Patient taking treatment at Tata memorial hospital
4. Patient willing to follow- up for further assessments at Tata Memorial Hospital
5. Indian nationality
|
|
| ExclusionCriteria |
| Details |
1. Patients with pre-existing neurological disorder
2. Pre- morbid neuromuscular disorders
3. Trisomy 21
4. Patients with vision or hearing impairment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess fine motor performance in children with Acute Lymphoblastic Leukemia undergoing chemotherapy using Bruininks- Oseretsky Test of Motor Proficiency-Second Edition (BOT-2) |
CHEMOTHERAPY WEEK 5 (BASELINE), WEEK 8, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 96, WEEK 108, WEEK 120 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To assess hand grip strength in children with Acute Lymphoblastic Leukemia undergoing chemotherapy using Jamar Hand dynamometer |
CHEMOTHERAPY WEEK 5 (BASELINE), WEEK 8, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 96, WEEK 108, WEEK 120 |
| • To assess pinch strength in children with Acute Lymphoblastic Leukemia undergoing chemotherapy using Jamar Pinch meter |
CHEMOTHERAPY WEEK 5 (BASELINE), WEEK 8, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 96, WEEK 108, WEEK 120 |
| • To assess handwriting in children with Acute Lymphoblastic Leukemia undergoing chemotherapy using handwriting assessment proforma |
CHEMOTHERAPY WEEK 5 (BASELINE), WEEK 8, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 96, WEEK 108, WEEK 120 |
| • To assess sensations in children with Acute Lymphoblastic Leukemia undergoing chemotherapy using departmental assessment proforma |
CHEMOTHERAPY WEEK 5 (BASELINE), WEEK 8, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 96, WEEK 108, WEEK 120 |
| • To assess cognition in children with Acute Lymphoblastic Leukemia undergoing chemotherapy using Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) |
CHEMOTHERAPY WEEK 5 (BASELINE), WEEK 8, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 96, WEEK 108, WEEK 120 |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acute Lymphoblastic Leukemia is one of the most common paediatric malignancies treated at our institute, affecting a significant number of children annually. Literature indicates that children with Acute Lymphoblastic Leukemia are at risk of motor and cognitive impairments due to intensive chemotherapy treatment. These impairments have been linked to reduced academic participation and lower rates of college enrolment. Early intervention has been emphasized as a crucial strategy to prevent academic difficulties and enhance long-term educational outcomes in this population. Occupational therapists are professionally qualified to identify and address deficits in upper extremity functional abilities and neurocognitive processing in the paediatric population and hence are better equipped in detecting subtle impairments, if any, in the hand functions and cognition in pediatric Acute Lymphoblastic Leukemia patients by periodic assessment and design targeted interventions for the same. Given the prevalence of Acute Lymphoblastic Leukemia and the intensive nature of its treatment, understanding the functional and cognitive challenges faced by these children and understanding the knowledge gap regarding the level of motor and cognitive performance and its impact on schooling as an occupation in Indian children with Acute Lymphoblastic Leukemia, we propose a prospective observational study aimed at the early identification of motor and cognitive impairments in paediatric patients with Acute Lymphoblastic Leukemia during chemotherapy. This study holds considerable potential to benefit future patients by facilitating early detection of treatment-related impairments, enabling timely interventions that address existing deficits and mitigate their long-term impact on quality of life, academic performance, and schooling outcomes. |